A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)
NCT ID: NCT01334918
Last Updated: 2024-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2011-04-26
2012-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Single Photon Emission Computed Tomography (SPECT)
Resting SPECT imaging was performed prior to regadenoson stress SPECT
imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
regadenoson
Administered by intravenous bolus.
technetium Tc99m sestamibi /technetium Tc99m tetrafosmin
Administered by intravenous infusion
Contrast
Administered by intravenous infusion.
Single Photon Emission Computed Tomography
Procedure/Surgery
Multidetector Computed Tomography
Procedure/Surgery
Multidetector Computed Tomography (MDCT)
Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
regadenoson
Administered by intravenous bolus.
technetium Tc99m sestamibi /technetium Tc99m tetrafosmin
Administered by intravenous infusion
Contrast
Administered by intravenous infusion.
Single Photon Emission Computed Tomography
Procedure/Surgery
Multidetector Computed Tomography
Procedure/Surgery
Interventions
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regadenoson
Administered by intravenous bolus.
technetium Tc99m sestamibi /technetium Tc99m tetrafosmin
Administered by intravenous infusion
Contrast
Administered by intravenous infusion.
Single Photon Emission Computed Tomography
Procedure/Surgery
Multidetector Computed Tomography
Procedure/Surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subjects must be ≥ 50 years of age
* Subject has met at least one of the following three criteria:
* has a suspected (clinical impression) or known diagnosis of coronary artery disease (CAD) with typical angina that has been referred from nuclear cardiology lab schedule or cardiac computed tomography (CT) schedule
* has stable symptoms with possible elective catheterization procedure scheduled and where further imaging may be beneficial;
* has known CAD from a previous invasive coronary angiography (ICA) performed more than 12 weeks prior to screening who now present with new cardiac symptoms
* Subject has been referred for a clinically indicated myocardial perfusion imaging procedure or Cardiac CT procedure for suspected moderate or high risk CAD
* Subject must abstain from eating and drinking 30 minutes prior and 30 minutes post study drug administration
* Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
* Subject must abstain from any intake of methylxanthine-containing foods and beverages within 12 hours prior to Day 1 visit through the Day 3 Follow-Up Visit, as these foods may alter regadenoson effects. Subject is able to safely abstain from theophylline use for 12 hours prior to study drug administration
Exclusion Criteria
* Subject has a history of a clinically significant illness (other than CAD), medical condition, or laboratory abnormality, which would preclude participation in the study
* Subject has renal dysfunction demonstrated by a glomerular filtration rate (GFR) \< 45 mL/min (calculated using Cockroft-Gault formula Note: Subjects with a GFR 45-60 mL/min will undergo a hydration procedure
* Female subject who is pregnant, lactating or of childbearing potential that refuses to use a medically acceptable form of contraception until the Telephone Follow up Visit is complete
* Female subject has a positive pregnancy test prior to randomization
* Subject has a history of second or third degree heart block or sinus node dysfunction unless the subject has a functioning pacemaker
* Subject has symptomatic hypotension (temporary and reversible conditions that no longer exist are allowed)
* Subject is allergic or intolerant to aminophylline, nitroglycerin or metoprolol
* Subject is allergic or intolerant to regadenoson or any of its excipients
* Subject is unable or unwilling to comply with the procedure schedule
* Subject has previously enrolled in this study or was enrolled in another regadenoson study sponsored by Astellas
* Subject has atrial fibrillation or significant arrhythmias which may result in decreased image quality for the imaging studies (CT and SPECT)
* Subject has high heart rate (\> 65 beats per minute) and contra-indications to administer beta-blockers (severe chronic obstructive pulmonary disease (COPD) or asthma, second and third degree atrioventricular block)
45 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Sutter Roseville Medical Center
Roseville, California, United States
Harbor UCLA Medical Center
Torrance, California, United States
Cardiovascular Research Center of South Florida
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Midwest Cardiology Associates, P.C.
Overland Park, Kansas, United States
Maine Research Associates
Auburn, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Oregon Health and Science University
Portland, Oregon, United States
Countries
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References
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Cury RC, Kitt TM, Feaheny K, Akin J, George RT. Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison. J Cardiovasc Comput Tomogr. 2014 Jan-Feb;8(1):2-12. doi: 10.1016/j.jcct.2013.09.004. Epub 2013 Oct 18.
Related Links
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Link to results on the Astellas Clinical Study Results website.
Other Identifiers
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3606-CL-2001
Identifier Type: -
Identifier Source: org_study_id